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临床试验/NCT03764358
NCT03764358Unknown不适用

Comparison of Tunneled Cuffed Dialysis Catheters Versus Arteriovenous Fistulae in Elderly or Multimorbid Patients

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
220
试验地点
2
主要终点
Composite primary end-point of any access related complication

研究概览

简要总结

Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index >6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of 60 and higher
  • CCI Score >6 when under 60 years
  • Patients with CKD G5 A1-3 with indication for hemodialysis
  • Stable clinical condition
  • Eligibility for both arteriovenous fistula on the upper extremitiesandTCC
  • Availability for follow-up.
  • Written informed consent.

排除标准

  • Uncontrolled infection at screening and/or CRP >5 mg/dl (normal <0.5 mg/dl) at screening.
  • Poor general condition of health or malignancy not in remission at screening
  • Major surgery within 12 weeks before screening.
  • Pre-existent vascular access.
  • Patient not eligible for any one of the vascular access options.

研究组 & 干预措施

Arteriovenous fistula

Active Comparator

干预措施: Arteriovenous Fistula (Device)

Tunneled Cuffed Catheter

Experimental

干预措施: Tunneled Cuffed Catheter (Device)

结局指标

主要结局

Composite primary end-point of any access related complication

时间窗: From placement of vascular access through study completion, an average of 3 years.

Loss of access, catheter related bloodstream infection/shunt infection and/or thrombosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guerkan SENGOELGE

Assoc. Prof. Priv.-Doz. Dr.

Medical University of Vienna

研究点 (2)

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